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Volume 12 Issue 1 Article 4 2005 Strictly Speaking about Ephedra: A Baseball Tragedy Helping to Strictly Speaking about Ephedra: A Baseball Tragedy Helping to Define the Dynamic between Warning Defect and Design Defect Define the Dynamic between Warning Defect and Design Defect Michael Kane Follow this and additional works at: https://digitalcommons.law.villanova.edu/mslj Part of the Entertainment, Arts, and Sports Law Commons, Food and Drug Law Commons, and the Torts Commons Recommended Citation Recommended Citation Michael Kane, Strictly Speaking about Ephedra: A Baseball Tragedy Helping to Define the Dynamic between Warning Defect and Design Defect, 12 Jeffrey S. Moorad Sports L.J. 97 (2005). Available at: https://digitalcommons.law.villanova.edu/mslj/vol12/iss1/4 This Comment is brought to you for free and open access by Villanova University Charles Widger School of Law Digital Repository. It has been accepted for inclusion in Jeffrey S. Moorad Sports Law Journal by an authorized editor of Villanova University Charles Widger School of Law Digital Repository.

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Page 1: Strictly Speaking about Ephedra: A Baseball Tragedy

Volume 12 Issue 1 Article 4

2005

Strictly Speaking about Ephedra: A Baseball Tragedy Helping to Strictly Speaking about Ephedra: A Baseball Tragedy Helping to

Define the Dynamic between Warning Defect and Design Defect Define the Dynamic between Warning Defect and Design Defect

Michael Kane

Follow this and additional works at: https://digitalcommons.law.villanova.edu/mslj

Part of the Entertainment, Arts, and Sports Law Commons, Food and Drug Law Commons, and the

Torts Commons

Recommended Citation Recommended Citation Michael Kane, Strictly Speaking about Ephedra: A Baseball Tragedy Helping to Define the Dynamic between Warning Defect and Design Defect, 12 Jeffrey S. Moorad Sports L.J. 97 (2005). Available at: https://digitalcommons.law.villanova.edu/mslj/vol12/iss1/4

This Comment is brought to you for free and open access by Villanova University Charles Widger School of Law Digital Repository. It has been accepted for inclusion in Jeffrey S. Moorad Sports Law Journal by an authorized editor of Villanova University Charles Widger School of Law Digital Repository.

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STRICTLY SPEAKING ABOUT EPHEDRA: A BASEBALL

TRAGEDY HELPING TO DEFINE THE DYNAMIC BETWEEN

WARNING DEFECT AND DESIGN DEFECT

I. INTRODUCTION

On August 17, 2003, Kiley Bechler spread the ashes of her re-

cently deceased husband, Steve Bechler, on the pitcher's mound at

Camden Yards.1 This solemn gesture marked an end to one chap-

ter of the tragic saga that began with the twenty-three year-old

pitcher's unexpected death.2

Just several months earlier, Steve Bechler reported to the Balti-

more Orioles spring training camp ten pounds overweight.3 To

lose weight for the upcoming baseball season, Bechler took an over-

the-counter dietary supplement called Xenadrine RFA-1

("Xenadrine"), which contains ephedra. 4 Bechler reportedly took

three Xenadrine capsules each morning, one capsule over the rec-

ommended dosage printed on the bottle. 5 On Friday, February 14,

1. See Thomas Loverro, Bechler has an eternal presence at Camden, WASH. TIMES,

Aug. 18, 2003, at C1 (describing how Kiley Bechler spread her husband's ashes on

Camden Yards' main pitcher's mound and two other pitching mounds located in

ballpark's bullpen after Sunday's Baltimore Orioles-New York Yankees game).

2. See id. ("'I think this is where he would want to be,' Kiley Bechler said. 'It

adds a little closure to everything that has been going on and brings a little bit ofjoy to a pretty sad situation."').

3. See Gary Washburn, Ephedrine cited in Bechler's death, at http://baltimore.ori-

oles.mlb.com/NASApp/mlb/bal/news/bal-news.jsp?ymd=20030226&content-id=204807&vkey=spt2003news&fext=.jsp (Feb. 26, 2003) (explaining Bechler's physi-

cal condition was not as it was in past seasons). Bechler was listed at 239 pounds

and reported to spring training weighing approximately 249 pounds. See id.

4. See id. (discussing how Xenadrine is used for weight-loss by increasing me-

tabolism speed and heart rate). Xenadrine is manufactured by both Cytodyne

Technologies and Phoenix Laboratories. See id.; see also Ex parte Gen. NutritionCorp., 855 So. 2d 475, 478 (Ala. 2003) (describing how woman's use of Xenadrine,which contains ephedra, may have contributed to her sudden cardiac death).

While Steve Bechler was taking Xenadrine with ephedra, it must be noted that an

ephedra-free version of the dietary supplement Xenadrine-EFX ("EFX") was on

the market and available for consumption. See Issues Relating to Ephedra-containing

Dietary Supplements: Hearings Before the Subcomm. on Oversight and Investigations of the

House Comm. on Energy and Commerce, 108th Cong. (2003) [hereinafter Hearings]

(prepared statement of Robert Chinery) (describing how Cytodyne Technologieslaunched ephedra-free Xenadrine-EFX in early 2002), available at http://energycommerce.house.gov/108/Hearings/07232003hearingl021/Chineryl640.htm.For a further discussion of ephedra, see infra notes 23-27 and accompanying text.

5. See Murray Chass, Pitcher's Autopsy Lists Ephedra as One Factor, N.Y. TIMES,

Mar. 14, 2003, at D5 (stating Xenadrine's recommended dosage as two tablets permorning and two tablets per afternoon).

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2003, Bechler reported to training camp and passed a routine phys-ical examination. 6 Later that day, Bechler completed the Orioles'first day of drills at spring training without incident.7 Two dayslater, however, Steve Bechler suddenly collapsed on the practicefield from heat exhaustion.8

Orioles' trainers examined the twenty-three year-old pitcher atthe training facility, but were unable to help him.9 Bechler wasrushed to the hospital where his temperature reached a staggering108 degrees, causing his body to overheat, leading to "cell death"and ultimately multiple system organ failure.1 0 At 10:10 a.m., onMonday, February 17, 2003, Steve Bechler died.1

Bechler's autopsy revealed that ephedra was a significant factorin the pitcher's death. 12 Later investigation revealed that Bechlersuffered from a history of abnormal liver functions and mild hyper-tension prior to the day of his collapse. 13

6. See Becky Dubin Jenkins, Physician explains Bechler's death, at http://balti-more.orioles.mlb.com/NASApp/mlb/bal/news/bal-news.jsp?ymd=20030217&content id=201272&vkey=spt2003news&fext=.jsp (Feb. 17, 2003) ("Bechler didnot report any problems to the doctor who examined him and was deemed 'fit togo' and 'fit to play.' Bechler did have a routine EKG in 1999, and it, too, wasnormal.").

7. See Becky Dubin Jenkins, O's Notes: Bechler taken to hospital, at http://balti-more.orioles.mlb.com/NASApp/mlb/bal/news/bal-newsjsp?ymd=20030216&content id=200789&vkey=spt2003news&fext=.jsp (Feb. 16, 2003) (discussing howOrioles' manager, Mike Hardgrove, commented that Bechler finished Friday's firstday drills, but he finished them tired). The very next day, Saturday, Bechler fin-ished most of the team drills, but was taken out of practice for disciplinary reasons.See id.

8. See id. (describing Bechler's participation in running drills before hecollapsed).

9. See id. (running through various events taking place during thirty-sevenminute time period from when trainers brought Bechler to Orioles' training roomat 11:35 a.m. until emergency personnel transported Bechler from field at 12:12p.m.).

10. SeeJenkins, supra note 6 (explaining Bechler's multiple organ failure wasdue to heatstroke).

11. See id. (describing events surrounding Bechler's death at North RidgeMedical Center in Fort Lauderdale, Florida). "Bechler's pregnant wife, Kiley, wasat his bedside when he died." Id.

12. See Chass, supra note 5, at D5 (attributing Bechler's death, in part, toephedra found in his system). "Releasing the toxicology report, Dr.Joshua Perper,the Broward County medical examiner, said, 'It is my professional opinion that thetoxicity of ephedra played a significant role in the death of Mr. Bechler, althoughit's impossible to define mathematically the contribution of each one of the factorsin his unfortunate death due to heatstroke."' Id. Dr. Perper revealed his findingsduring a press conference and in a detailed thirteen page report on Bechler'sdeath. See id.

13. See id. (explaining how interviews and previous medical examinations re-vealed other risk factors which may have contributed to Bechler's death).

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In response to her husband's death, Kiley Bechler sued themakers of Xenadrine in a Florida federal court.14 She is asking for600 million dollars in a products liability lawsuit for wrongfuldeath. 15 The complaint sets forth six claims against thedefendants.

16

This Comment focuses on two of Kiley Bechler's strict productsliability claims, specifically design defect and warning defect. 17 Byaddressing the circumstances surrounding Steve Bechler's death,this Comment explains the relationship between a product's warn-ing and its design in a strict products liability lawsuit.18 Section IIprovides a general background of Florida strict products liabilitylaw for design defect and warning defect.19 Section III applies Flor-ida law to the facts surrounding Steve Bechler's death.20 Section IVdiscusses certain practical considerations concerning Bechler's caseand the policy-driven ramifications of Florida's stance on strictproducts liability law. 2 1 Section IV also highlights new develop-

14. See Peter Schmuck, Bechler's widow sues companies for $600M; Lawsuit allegesephedra killed Orioles pitcher, BALT. SUN, July 18, 2003, at DI (stating Kiley Bechlerfiled her lawsuit in United States District Court in Fort Lauderdale). Kiley Bechlerfiled her lawsuit against Cytodyne Technologies, Phoenix Laboratories, andCytodyne president Robert Chinery on Wednesday, July 16, 2003. See id. The law-suit also named an unidentified company which sold the dietary supplement toSteve Bechler. See id.

15. See id. (alleging defendants disregarded safety of consumers in order tobolster profits).

16. See Complaint of Kiley Bechler at 11-16, Kiley Bechler v. Cytodyne Techs.,Inc. (S.D. Fla. July 16, 2003) (No. 03-61369) [hereinafter Complaint] (claiming neg-ligence, breach of express warranty, breach of implied warranty, and three countsof strict liability for inherently, unreasonably dangerous product, failure to warn,and misrepresentations).

17. For a discussion of design defect, see infra notes 47-86 and accompanyingtext. For a discussion of warning defect, see infra notes 87-115 and accompanyingtext.

18. For a discussion of the relationship between warning defect and designdefect, see infra notes 156-74 and accompanying text.

19. For a discussion of pertinent Florida strict products design defect caselaw, see infra notes 47-86 and accompanying text. For a discussion of pertinentFlorida strict products warning defect case law, see infra notes 87-115 and accom-panying text.

20. For a discussion of the application of the consumer expectations test tothe circumstances surrounding Steve Bechler's death, see infra notes 119-32 andaccompanying text. For a discussion of the application of the risk-utility test to thecircumstances surrounding Steve Bechler's death, see infra notes 133-44 and ac-companying text.

21. For a discussion of Florida's policy-driven view of strict products liabilitylaw, see infra notes 179-86 and accompanying text.

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ments, including recent FDA action, and the grim future ofephedra.

22

II. BACKGROUND

A. The Attack on Ephedra

Ephedra, also known as ma huang, is a natural substance de-rived from plants. 23 In China, ephedra has been used forthousands of years to treat various respiratory ailments.24 Today,the plant is crushed and formulated into pills, teas, and otherforms, and sold as dietary supplements.25 Dietary supplements arepromoted by the industry as diet aids, muscle builders, and energyboosters.26 These claims, however, have never been substantiated. 27

The federal government, through the Dietary Supplement andHealth Education Act of 1994 ("DSHEA"), does not require manu-facturers of dietary supplements to prove product safety or effec-tiveness before placing them on the market.28 Instead, before adietary supplement can be removed from the market, the FederalDrug Administration ("FDA") must prove that the supplementis unsafe.2 9 Under this regulatory system, dangerous products,

22. For a discussion of current events regarding ephedra, see infra notes 187-95 and accompanying text.

23. See The Origins, Uses and Risks of a Supplement, N.Y. TIMES, Dec. 31, 2003, atA14 [hereinafter Supplement] (explaining origins of ephedra). "Ephedra is definedas '1. Any of various gymnospermous, mostly shrubby plants of the genus Ephedra,some of which are used as a source of ephedrine. 2. A stimulant, often sold as pillsor tablets, derived from a plant of this genus."' Ex parte Gen. Nutrition Corp., 855So. 2d 475, 478 n.2 (Ala. 2003) (quoting AMERIcAN HERITAGE DICTIONARY OF THEENGLISH LANGUAGE (4th ed., Houghton Mifflin Co. 2000)).

24. See Supplement, supra note 23, at A14 (describing origins and medical usesof ephedra in China). "Ephedra contains two alkaloids, ephedrine andpseudoephidrine. These compounds can combat congestion and ease breathingin some conditions." Id.

25. See id. (finding some form of ephedra in nearly 200 different dietary sup-plements). All of these supplements were sold without a prescription. See id.

26. See id. ("Manufacturers and retailers have claimed the herb is good forweight control, building muscle and boosting energy.").

27. See Mark B. McClellan, Remark of the Commissioner of Food and Drugs, 58FooD & DRUG LJ. 191, 200 (2003) (describing how manufacturers of ephedraproducts make unsubstantiated claims about enhancing athletic performance).

28. See Lauren J. Sloane, Comment, Herbal Garden of Good and Evil: The Ongo-ing Struggles of Dietaiy Supplement Regulation, 51 ADMIN L. REV. 323, 326-27 (1999)(defining obligations of FDA when regulating dietary supplements); see also Don-ald G. McNeil, Jr., Sometimes, the Labels Lie, N.Y. TIMES, Sept. 9, 2003, at F7 (discuss-ing dietary supplement manufacturers do not have to prove their products work)."That's how products like ephedra end up on shelves and in magazine advertise-ments before it's discovered that they can kill people." Id.

29. See Sloane, supra note 28, at 326 (showing difficulties with regulating diet-ary supplements after imposition of DSHEA).

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like ephedra, are pulled off the shelves only after the damage isdone.3

0

The eighteen billion dollar-per-year dietary supplement indus-try has recently come under attack because of its deceptive market-ing practices. 31 In fact, Cytodyne Technologies, Inc., the makers ofXenadrine, recently lost a 12.5 million dollar lawsuit for false adver-tising practices.3 2 In addition, the commissioner of the FDA haspublicly professed that the agency is chasing down the makers ofephedra products for their "unsubstantiated claims. '33

The FDA is not alone; plaintiffs nationwide are attacking themanufacturers of dietary supplements containing ephedra, claim-ing their products are unsafe and should be removed from the mar-ket immediately. 34 For instance, the family of a woman whorecently died while exercising on a high school track sued the mak-ers of Xenadrine for her unexpected death. 35 In addition, KelciStringer, the widow of former Minnesota Vikings pro-bowler KoreyStringer, has made accusations that ephedra contributed to her

30. See Winnie Hu, Albany Leaders Reach Accord On Ephedra Ban, N.Y. TIMES,

June 11, 2003, at B6 (stating New York state legislators agreed to ban ephedra salesstatewide). With approval from Governor Pataki, New York would join Illinois asonly the second state banning over-the-counter sales of ephedra after SteveBechler's death. See id. "The Food and Drug Administration has reported 123deaths associated with ephedra since 1993. Dietary supplements, unlike drugs, donot need the agency's approval before going on the market." Id.

31. See Ford Fessenden, Studies of Dietary Supplements Come Under Growing Scru-tiny, N.Y. TIMES, June 23, 2003, at Al (explaining how industry research is less thanscientific and frequently misleading to consumers).

32. See id. (describing how makers of ephedra and other dietary supplementsmisuse data in scientific studies). "Cytodyne ... exaggerated the findings ofclinical trials it commissioned, Superior Court Judge Ronald L. Styn said in rulingon a class action suit, but [Cytodyne] had also cajoled some researchers into fudg-ing results in published scientific articles." Id.; see also Ephedra: Cytodyne to Pay $12.5Million in 'Xenadrine' case, at http://www.legalnewswatch.com/news_208.html (May30, 2003) (describing both sides' reactions to court's decision).

33. See McClellan, supra note 27, at 200 (discussing need for stronger warninglabels on any ephedra products still marketed). The commissioner stated: "We arealso executing a series of actions against ephedra products making unsubstantiatedclaims, for example about sports performance enhancement, and against manufac-turers that in effect are marketing alternatives to street drugs." Id.

34. See Register, Big Class Action, at http://www.bigclassaction.com/classac-tion/ephedra2.html (last visited Nov. 14, 2004) (indicating first nationwide classaction against leading ephedra makers was filed). Plaintiffs to this class action law-suit are seeking monetary compensation for injuries and death, reimbursement ofpayments made for ephedra containing products, a recall of all dietary supple-ments containing ephedra, a medical monitoring fund, and a public statement bythe makers of ephedra regarding the dangers of their products. See id.

35. See Ex parte Gen. Nutrition Corp., 855 So. 2d 475, 478 (Ala. 2003) ("Theautopsy report stated, among other things, that 'her death is consistent with a sud-den cardiac death."'). The woman allegedly purchased the Xenadrine at a localGeneral Nutrition Center ("GNC") retail store in Newport News, Virginia. See id.

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husband's heat stroke and death in 2001.36 Kiley Bechler is leadingthe attack on the ephedra industry through her 600 million dollarlawsuit, and her weapon of choice is strict products liability.3 7

B. Strict Products Liability38

In West v. Caterpillar Tractor Co.,3 9 the Florida Supreme Courtadopted the doctrine of strict liability as set out in the Restatement(Second) of Torts Section 402A.40 A manufacturer will be heldstrictly liable if the plaintiff proves that: "(1) a product (2) pro-duced by a manufacturer (3) was defective or created an unreason-ably dangerous condition (4) that proximately caused (5) injury. '41

A plaintiff does not need to prove that a manufacturer was negli-gent to succeed in a strict products liability action. 42 The policy

36. See Chris Williams, Vikings raise ephedra as 'causal link' to Stringer's fatal heat-stroke, USA TODAY.COM, Feb. 25, 2003 (commenting on Kelci Stringer's 100 milliondollar wrongful death lawsuit against Vikings), available at http://www.usatoday.com/sports/football/nfl/vikings/2003-02-25-stringer-ephedrax.htm. RippedFuel, a dietary supplement containing ephedra, was found in Stringer's locker onthe day of his death. See id. The examining doctors did not find any direct evi-dence that Stringer took Ripped Fuel on the morning of his death. See id. TheNational Football League banned ephedra after Stringer's death. See id.

37. See Complaint, supra note 16, at 11-14 (detailing Kiley Bechler's strict liabil-ity claims).

38. This Comment focuses on Florida tort law because the federal courthearing Kiley Bechler's lawsuit will apply Florida law. For further discussion on theapplication of Florida law, see supra note 14 and accompanying text.

39. 336 So. 2d 80 (Fla. 1976).40. See id. at 87 (indicating Florida followed trend of numerous states by

adopting doctrine of strict liability); see also RESTATEMENT (SECOND) OF TORTS

§ 402A (1965). Section 402A provides:(1) One who sells any product in a defective condition unreasonably

dangerous to the user or consumer or to his property is subject toliability for physical harm thereby caused to the ultimate user or con-sumer, or to his property, if(a) the seller is engaged in the business of selling such a product,

and(b) it is expected to and does reach the user or consumer without

substantial change in the condition in which it is sold.(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the preparation andsale of his product, and

(b) the user or consumer has not brought the product from or en-tered into any contractual relation with the seller.

Id.41. Edward M. Chadbourne, Inc. v. Vaughn, 491 So. 2d 551, 553 (Fla. 1986)

(finding insufficient proof of proximate cause, and therefore, manufacturer couldnot be held strictly liable). If the plaintiff proves all five points, the manufacturerof the defective product is strictly liable. See id.

42. See Ferayorni v. Hyundai Motor Co., 711 So. 2d 1167, 1170-71 (Fla. Dist.Ct. App. 1998) (noting Florida strict products liability law does not require negli-gence). "In fact [manufacturers] can be found liable even though [they were]

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surrounding strict products liability is premised on the manufac-turer's ability to better bear the costs of injuries resulting from de-fective products. 43

In a products liability action based on strict liability, a productis considered defective if it is in a condition unreasonably danger-ous to the consumer.44 The three theories used when consideringa product's defectiveness are design defect, manufacturing defect,and warning defect.45 Because this Comment focuses on the rela-tionship between design defect and warning defect, manufacturingdefect will not be discussed.46

1. Design Defect

When determining whether a product is defectively designed, acourt may choose between two tests. 47 Under Florida law, trialcourts are given wide discretion to use either the consumer expec-tation test or the risk-utility test.4 8 In some instances, Florida courtshave even applied both tests concurrently. 49 As a result, all litigants

utterly non-negligent." Id. at 1171 (quoting Moorman v. Am. Safety Equip., 594So. 2d 795, 800 (Fla. Dist. Ct. App. 1992)).

43. See Cassisi v. Maytag Co., 396 So. 2d 1140, 1150 (Fla. Dist. Ct. App. 1981)("[T]he purpose of strict liability is to ensure that the costs of injuries resultingfrom defective products be borne by their makers who put them into the channelsof trade rather than by injured persons who ordinarily are powerless to protectthemselves."); see also West, 336 So. 2d at 92 (stating similar rationale for holdingmanufacturers liable for defective products).

44. See Cassisi, 396 So. 2d at 1143-44 (stating products are not required to beboth defective and unreasonably dangerous). "On first impression, the [Second]Restatement may seem to require proof that the product be both defective andunreasonably dangerous. That, however, is not the case [in Florida]." Id. at 1143.

45. SeeJennings v. BIC Corp., 181 F.3d 1250, 1255 (11th Cir. 1999) (applyingFlorida law); see also Ferayorni, 711 So. 2d at 1170 (noting three distinct theoriesthat define defective products).

46. For a discussion of the relationship between warning defect and designdefect, see infra notes 156-74 and accompanying text.

47. See Standard Jury Instructions-Civil Cases (99-1), 778 So. 2d 264, 271 (Fla.2000) (stating two tests for design defect are consumer expectation and risk-utilitytests).

48. See id. at 272 (stating either test is acceptable, or even both); see also Spen-cer H. Silverglate, The Restatement (Third) of Torts: Product Liability-The Tension Be-tween Product Design and Product Warnings, 75 FLA. B.J. 10, 14 (2001) (describingconfusion that exists with Florida's standard jury instructions in design defectcases). "In contrast, the Third Restatement adopts the risk-utility balancing test todetermine design defect [, however,] . . .consumer expectations ... may be con-sidered as part of the risk-utility balancing test." Id.

49. See Taylor v. Gen. Motors Corp., 875 F.2d 816, 818-19 (11th Cir. 1989)(recognizing two theories of strict liability for design defect and applying bothtests); see also Zimmer, Inc. v. Birnbaum, 758 So. 2d 714, 715 (Fla. Dist. Ct. App.2000) (asserting validity of instructingjury on both theories).

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in design defect cases must be keenly aware of the ramifications ofboth tests in design defect claims.50

a. Consumer Expectation Test

The consumer expectation test provides that "[a] product isunreasonably dangerous because of its design if the product fails toperform as safely as an ordinary consumer would expect when usedas intended or in a manner reasonably foreseeable by the manufac-turer. "51 While the consumer expectation test is easily applied tomanufacturing defect claims, the test is generally more difficult toapply to design defect claims.52

In Jennings v. BIC Corp.,53 a three year-old boy accidentally lithis brother's pajamas on fire with a BIC lighter. 54 The boys'mother sued BIC for her son's personal injuries. 55 Her lawsuit al-leged BIC's failure to provide a child proof feature rendered thelighter defective in design. 56 The case was to be tried before ajuryin the United States District Court for the Middle District of Flor-

50. See Zimmer, 758 So. 2d at 715 (describing how appellate review may beprecluded in cases where both consumer expectation test and risk-utility test wereused injury's general verdict). In Zimmer, the plaintiff was precluded from appeal-ing his case because the court could not decipher which test the jury applied incoming to its verdict. See id. The plaintiff claimed that the trial court erred wheninstructing the jury on the consumer expectation test. See id. Affirming the jury'sruling for the defendant, the court stated:

The jury charge gave the jury two standards for determining whether theproduct was unreasonably dangerous - the ordinary consumer test andthe risk benefit test. Zimmer concedes that the risk benefit test was ap-propriate to use in this case. The verdict form did not require the jury toidentify its basis for deciding that the product was defective. Zimmer didnot object at trial to the use of the verdict form. The jury might properlyhave decided that the rods were defective based on a risk benefit analysis.Even if we found error in the definition of the ordinary consumer test orin its submission to the jury, under the two issue rule, Zimmer is unableto demonstrate prejudice to justify a reversal.

Id. An attorney should make a timely objection when he or she is faced with ageneral verdict, and the jury has been instructed on both the consumer expecta-tion test and the risk-utility test. See id.

51. Standard Jury Instructions, 778 So. 2d at 271 (setting forth specific jury in-struction for consumer expectation test).

52. See Cassisi v. Maytag Co., 396 So. 2d 1140, 1145 (Fla. Dist. Ct. App. 1981)(describing difficulties in applying consumer expectation test to design defect andwarning defect claims).

53. 181 F.3d 1250 (l1th Cir. 1999).54. See id. at 1253 (observing lighter did not have child-proof feature).55. See id. (stating mother's response to son's injury).56. See id. (alleging design defect because lighter was unreasonably danger-

ous). The lawsuit also alleged that 7-Eleven was liable for selling the defectivelighter and the store that sold the flammable pajamas was liable for distributingflammable pajamas. See id.

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ida.5 7 The court, however, granted BIC's motion for summary judg-ment and Jennings' case was dismissed. 58 Jennings appealed thedistrict court's summary judgment.59 She contended the courterred in finding that BIC had no duty to child-proof its lighters. 60

The issue on appeal was "limited to whether the alleged design de-fect of the lighter, i.e., its lack of childproof features, render[ed] itunreasonably dangerous." 61

Florida courts utilize both the consumer expectation test andthe risk-utility test to decide whether a product is unreasonably dan-gerous.62 In Jennings, the court focused on the consumer expecta-tion test.63 Both tests require the jury to use an objective standard

to determine whether the product is defective. 64 Using the con-sumer expectation objective standard, the court judged the defec-tiveness of the lighter from an ordinary consumer's standpoint,rather than from an ordinary three year-old child's standpoint.65

As a matter of law, the court held that lighters lacking child-prooffeatures are not defective. 66

57. See id. at 1253 (discussing procedural history).58. SeeJennings, 181 F.3d at 1253 (explaining facts and procedural history).

Originally, the lawsuit was filed in Florida state court, but the defendant removedit to federal court. See id. While the court granted BIC's motion for summaryjudgment, the jury rendered verdicts in favor of the other defendants. See id. at1253-54.

59. See id. at 1254 ("Jennings appeals the trial court's grant of summary judg-ment to BIC, its denial of leave to amend, and its evidentiary rulings. Jennings alsoappeals the jury verdict on the ground that the trial court gave erroneousinstructions.").

60. See id. (arguing BIC should have designed lighter with child-prooffeatures).

61. Id. at 1255 (emphasis in original) (determining design defectiveness byusing objective standards, not subjective standards).

62. See Standard Jury Instructions-Civil Cases (99-1), 778 So. 2d 264, 271 (Fla.2000) (articulating Florida Supreme Court's jury instructions for strict liability, de-sign defect). "A product is unreasonably dangerous because of its design if [theproduct fails to perform as safely as an ordinary consumer would expect when usedas intended or in a manner reasonably foreseeable by the manufacturer] [or] [therisk of danger in the design outweighs the benefits]." Id. (alterations in original).The jury instructions for design defect give Florida courts flexibility to define "un-reasonably dangerous" by using the consumer expectation test, the risk-utility test,or both. See id. at 272. The Florida Supreme Court does not prefer either test. Seeid. Therefore, trial courts must determine what test is appropriate on a case-by-case basis. See id.

63. SeeJennings, 181 F.3d at 1255 (applying consumer expectation test).64. See id. (differentiating between two tests). "The consumer expectation

test requires consideration of the ordinary consumer's expectations." Id.65. See id. (finding lighter could be defective by three year-old child's subjec-

tive standard).66. See id. at 1255-56 (declaring neither consumer expectation test or risk-

utility test use subjective "child's-perspective standard" to find defectiveness); seealso Standard Jury Instructions, 778 So. 2d at 271 (using ordinary consumer standard

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In a vigorous dissent, Judge Barkett posited that the caseshould be sent to the Florida Supreme Court for clarification onthe existing state of Florida strict products liability law, specificallydesign defect. 67 The dissent suggested a jury could find BIC light-ers without child-proof features defective in design under the objec-tive ordinary consumer standard. 68 This objective standardrequires contemplating the "consideration of the ordinary con-sumer's expectations."69 Ordinary consumer expectations reasona-bly include the expectation of young children playing withlighters. 70 The dissent asserted that "in light of the high casualtyrate and the obviousness of the danger, a jury could well find BIClighters to be defectively designed under an objective, ordinary con-sumer standard."71

Furthermore, the majority in Jennings limited a manufacturer'sliability to situations where a product is used only as intended. 72

The Florida standard jury instruction for the consumer expectationtest allows ajury to find a defendant liable when a product is usedin a foreseeable manner or as intended. 73 By limiting liability to

for consumer expectation test). The ultimate burden of persuasion is on theplaintiff to prove the manufacturer's product is unreasonably dangerous. See id. at272.

67. SeeJennings, 181 F.3d at 1260 (Barkett,J., dissenting) (explaining there isno binding precedent on point to support majority's holding).

68. See id. at 1261 (agreeing with majority that objective analysis was proper).69. See id. at 1260 (considering "normal public expectation of danger" is an-

other way to phrase ordinary consumer expectations). The dissent believed thatthe majority was erroneous in finding that the "normal public expectation of dan-ger" of lighters did not include the probability that children could set fires. See id.at 1261.

70. See id. at 1260-61 (noting majority puts forth evidence of apparent dangersinvolved when children play with lighters). The dissent stated:

However, given that, by the majority's own admission, "140 people, in-cluding 125 children, are killed each year in fires caused by children play-ing with lighters," it is hard to credit the conclusion that the "normalpublic expectation of danger" would not include the risk of fires socaused, and that expectation of such a risk would arise only if oneadopted "a subjective, child's-perspective standard."

Id. (citations omitted).71. Id. at 1261 (arguing summary judgment in favor of BIC was

inappropriate).72. SeeJennings, 181 F.3d at 1261 (BarkettJ., dissenting) (stating majority mis-

interpreted previous precedent set forth in High v. Westinghouse Elec. Corp., 610So. 2d 1259 (Fla. 1992)). "The majority posits that a 'manufacturer is [strictly]liable only when the product is used as intended,' and asserts, on the basis of High,that a child's use of a cigarette lighter to set fire to things that are not intended tobe burned is an unintended use under Florida law." Id. at 1261 (alterations inoriginal).

73. See Standard Jury Instructions-Civil Cases (99-1), 778 So. 2d 264, 271 (Fla.2000) (allowing jury to find liability for any foreseeable use or intended use ofproducts).

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only intended uses, the majority excluded any reasonably foresee-able use, or misuse, as a basis to find BIC liable for design defect.74

Accordingly, had the majority in Jennings applied the reasonablyforeseeable use standard, it may have reached a different result.75

The reasonably foreseeable use standard will ultimately play a rolein Bechler's case. 76

b. Risk-Utility Test

Florida courts also apply the risk-utility test to decide whether aproduct is defectively designed. 77 The risk-utility test requires bal-ancing the utility of the product against the risk it creates. 78 If aproduct's risk outweighs its utility, then the product's design is de-fective. 79 When applying the risk-utility test, courts find ProfessorWade's seven factors helpful.80

74. See Jennings, 181 F.3d at 1261 (Barkett, J., dissenting) (concluding thatHigh provides no support for majority's finding that "manufacturers are not strictlyliable for injuries caused by reasonably foreseeable uses of their products").

75. See id. (predicting different result if majority had applied reasonableforeseeabilty standard).

76. See Standard Jury Instructions, 778 So. 2d at 271 (noting foreseeable use, ormisuse, will not preclude jury from entering verdict for plaintiff). For a discussionof Steve Bechler's foreseeable misuse, see infra notes 128-32 and accompanyingtext.

77. See Radiation Tech., Inc. v. Ware Constr. Co., 445 So. 2d 329, 331 (Fla.1983) (applying risk-utility test to determine whether product was unreasonablydangerous); see also RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2 re-

porter's note, cmt. d, § 11(B) (1998) (stating Florida law does not explicitly requireproof of alternative design in design defect cases, however, it may be implicit thatproof of alternative design is needed to prove design defect).

78. See RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2 reporter'snote, cmt. d, § II(B) (1998) (discussing importance of reasonable alternative de-sign in design defect cases where risk-utility test is applied). "Under risk-utilitybalancing the likelihood and magnitude of foreseeable harm is balanced againstthe burden of precaution against the anticipated harm." Id.

79. See id. (explaining risk-utility test).80. See Sperry-New Holland v. Prestage, 617 So. 2d 248, 256 (Miss. 1993) (rec-

ommending trial courts apply Professor Wade's seven factors). Professor Wade'sseven factors are:

(1) The usefulness and desirability of the product - its utility to the userand to the public as a whole.(2) The safety aspects of the product - the likelihood that it will causeinjury, and the probable seriousness of the injury.(3) The availability of a substitute product which would meet the sameneed and not be as unsafe.(4) The manufacturer's ability to eliminate the unsafe character of theproduct without impairing its usefulness or making it too expensive tomaintain its utility.(5) The user's ability to avoid danger by the exercise of care in the use ofthe product.(6) The user's anticipated awareness of the dangers inherent in the prod-uct and their avoidability, because of general public knowledge of the

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The risk-utility test is another way to determine whether a

product design is unreasonably dangerous to consumers.8' Over

the last decade, the national judicial trend has been to apply the

risk-utility test instead of the consumer expectation test.82 Courts

have recognized that the risk-utility test provides a useful balance,

protecting both consumers and manufacturers.8 3

While the risk-utility test is separate and distinct from the con-

sumer expectation test, the risk-utility test may encompass some

consumer expectations in its balancing approach. 4 For instance,

in design defect claims, the risk-utility test may allow for consumer

expectations to be balanced against the gravity of harm that could

result from the product, the availability of a safer design, and the

economic feasibility of a safer design. 85 Inevitably, certain con-

sumer expectations will creep into the risk-utility balancing

formula.8 6

obvious condition of the product, or of the existence of suitable warnings

or instructions.(7) The feasibility, on the part of the manufacturer, of spreading the loss

by setting the price of the product or carrying liability insurance.

Id. at 256 n.3 (quoting John W. Wade, On the Nature of Strict Tort Liability for Prod-

ucts, 44 Miss. L.J. 825, 837 (1973)).81. See Radiation Tech., 445 So. 2d at 331 (applying risk-utility test and not

consumer expectation test to determine design defect). The Supreme Court of

Florida stated:The term "unreasonably dangerous" more accurately depicts liability of a

manufacturer or supplier in that it balances the likelihood and gravity of

potential injury against the utility of the product, the availability of other,

safer products to meet the same need, the obviousness of the danger,

public knowledge and expectation of the danger, the adequacy of instruc-

tions and warnings on safe use, and the ability to eliminate or minimize

the danger without seriously impairing the product or making it unduly

expensive.Id.

82. See Speny-New Holland, 617 So. 2d at 255 (recognizing risk-utility test "has

become the trend in most federal and state jurisdictions").

83. See id. at 256 (pointing out consumers and manufacturers benefit from

courts applying risk-utility test).

84. See Cassisi v. Maytag Co., 396 So. 2d 1140, 1144-45 (Fla. Dist. Ct. App.

1981) (mentioning isk-utility balancing approach may include consumer expecta-

tions of product utility).85. See id. at 114546 (explaining burden shift to defendant to prove product's

design is not defective). The court holds:Once the plaintiff establishes a prima facie case showing that his injuries

were caused by the product's design, the burden is shifted to the defen-

dant to prove the design was not defective by presenting evidence of fac-

tors, such as gravity of the danger posed by the challenged design, the

feasibility of a safer design, the financial cost of the improved design, etc.

Id. (emphasis in original).86. See Wade, supra note 80, at 837 (accounting for certain factors in risk util-

ity analysis that are similar to consumer expectations). Wade's sixth factor ac-

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2. Warning Defect

The Supreme Court of Florida has not explicitly adopted astandard jury instruction for strict liability failure to warn. 87 In fact,the court chose not to develop a standard jury instruction.88 It de-cided to await "further development of Florida law" before taking aspecific position on strict liability failure to warn. 89 Therefore, Flor-ida courts are free to adopt their own jury instructions for claims ofstrict liability warning defect, which has created considerable confu-sion throughout the legal community. 90

In Ferayorni v. Hyundai Motor Co.,91 a seventeen year-old girl waskilled in a car accident.92 She was driving a 1990 Hyundai Excelequipped with an automatic shoulder belt and a manual lap belt.93

At the time of impact, the decedent was not properly utilizing thevehicle's restraint system.94 Specifically, she was not wearing the lapbelt and she improperly placed the shoulder harness under herarm, not over her shoulder.95 The improperly placed shoulder har-

product and their avoidability, because of general public knowledge of the obviouscondition of the product .... " Id. For a discussion of Professor Wade's sevenfactors, see supra note 80 and accompanying text.

87. See Standard Jury Instructions-Civil Cases (99-1), 778 So. 2d 264, 271-72(Fla. 2000) (declining to adopt standard jury instruction for strict liability failure towarn). There are, however, standard jury instructions for strict liability design de-fect and manufacturing defect. See id. at 271.

88. Id. at 272 (describing explicitly that Florida does not have standard juryinstruction for strict liability warning defect). Because Florida does not have auniform jury instruction, the lower courts are free to come up with their own juryinstructions for strict liability failure to warn. See id.

89. Id. (noting Supreme Court of Florida is awaiting further developments inFlorida law before creating standard jury instruction for warning defect). Thecourt is offering a flexible approach until an adequate standard jury instruction isadopted. See id.

90. See Michael Flynn, The Healthy Debate: A Proposal for the Addition of NegligentFailure to Warn and Strict Liability Failure to Warn Jury Instructions to the florida Stan-dard Jury Instructions for Product Liability Cases, 25 NOVA L. REv. 267, 268 (2000)(finding confusion among attorneys and judges throughout Florida's legal com-munity). "Absent this guidance from the supreme court, trial lawyers and trialjudges scramble to put together jury instructions of which neither the lawyers, northe judges, can be confident will hold up on appeal." Id. Flynn describes this as aneedless debate. See id.

91. 711 So. 2d 1167 (Fla. Dist. Ct. App. 1998).

92. See id. at 1169 (mentioning decedent's car was struck by another vehicle).

93. See id. (describing Hyundai Excel's restraint system). "A 'manual' seatbeltmust be applied by the occupant, while a 'passive' seatbelt is one which automati-cally moves into place around the occupant." Id. at 1169 n.1.

94. See id. at 1169 (noting improper use of seatbelt).

95. See id. (illustrating decedent's misuse of vehicle's restraint system).13

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ness caused internal injuries, which were the undisputed cause ofher death. 9 6

Ferayorni's estate sued Hyundai for failing to warn of the riskassociated with improper use of the seatbelt.97 At trial, the juryfound for the defendant Hyundai. 98 The estate appealed, claimingthe trial court improperly instructed the jury on the strict liabilityfailure to warn claim.99 On appeal, the court remanded the casefor a new trial only on this claim. 100 In doing so, the court clarifiedstrict liability failure to warn law in Florida. 10 1

Traditionally, the negligence of a manufacturer was irrelevantwhen dealing with strict products liability claims; "[h]owever, aclaim of strict liability arising specifically from a failure to warn maybe an exception to the generally recognized distinction betweennegligence and strict liability."1 02 Courts have struggled overwhether proof of manufacturers' knowledge of their products' dan-gerous tendencies should be a consideration in strict liability failureto warn claims. 103

In Ferayorni, the court employed a hybrid approach. 1 04 It main-tained the knowledge requirement to support a claim of strict liabil-ity for failure to warn. 10 5 The court, however, did not go as far asequating strict liability failure to warn with negligent failure to

96. Ferayorni, 711 So. 2d at 1169 (deeming decedent's death to be direct resultof her internal injuries).

97. See id. ("The estate's theory of the case was that Hyundai was aware thatsmaller drivers experience 'neck-cutting' from the shoulder harness and respondby wearing the shoulder harness under their arms.").

98. See id. (noting estate's complaint included claims of design defect andinadequate warning).

99. See id. (stating Ferayorni's alleged improperjury instructions were given tojury at trial).

100. See id. at 1173 (declaring trial court incorrectly failed to instruct jury onstrict liability failure to warn).

101. See Ferayorni, 711 So. 2d at 1173 (instructing lower court to apply juryinstructions for strict liability failure to warn).

102. Id. at 1171; see also West v. Caterpillar Tractor Co., 336 So. 2d 80, 90 (Fla.1976) ("Strict liability means negligence as a matter of law or negligence per se,the effect of which is to remove the burden from the user of proving specific actsof negligence.").

103. See Ferayomi, 711 So. 2d at 1170 (deciding whether to incorporate negli-gence principles into strict liability failure to warn claims). "The issue, specifically,is whether a claim of strict liability failure to warn requires, like its counterpart innegligence, proof that the manufacturer knew or should have known of the prod-uct's dangerous propensities." Id. at 1171.

104. See id. at 1172 (deciding to adopt neither negligence based nor purestrict liability approach in failure to warn claims).

105. See id. (finding it unnecessary to completely dispose of actual knowledgeor constructive knowledge requirements in strict liability failure to warn claims).

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warn. 11°6 By following the Supreme Court of California's decision in

Anderson v. Owens-Coming Fiberglass Corp.,'07 the Ferayorni court

seemed to find a middle ground.10 8

In Anderson, the Supreme Court of California reasoned that

completely eliminating the knowledge requirement would turn

strict liability failure to warn into absolute liability.109 Strict liability

failure to warn "require[s] a plaintiff to prove only that the defen-

dant did not adequately warn of a particular risk that was known or

knowable in light of the generally recognized and prevailing best sci-

entific and medical knowledge available at the time of manufacture

and distribution."'110 Therefore, the reasonableness of a manufac-

turer's failure to warn is irrelevant in a strict products liability fail-

ure to warn case. I1 '

After Ferayorni, Florida courts recognized that "manufacturers

are not required to warn of every risk which might be remotely sug-

gested by any obscure tidbit of available knowledge, but only of

those risks which are discoverable in light of the 'generally recognized

and prevailing best' knowledge available."' 2 Aside from knowability,manufacturers have a duty to warn about the dangers associated

with their products when these hazards are not obvious or well

known to consumers. 1 3 If a warning is required, the adequacy of

the warning is usually a question left to the jury. 1 4 Nevertheless,when a warning is "'accurate, clear and unambiguous"' ajudge may

decide the warning is adequate as a matter of law." 5

106. See id. (holding strict liability failure to warn claims do not require prov-ing negligence).

107. 810 P.2d 549 (Cal. 1991).

108. See Ferayorni, 711 So. 2d at 1172 (claiming correct balance was establishedin Anderson).

109. See Anderson, 810 P.2d at 552 (finding absolute liability contrary to publicpolicy). If manufacturers were held liable for unknowable dangers, they would bediscouraged from developing new products for fear of liability. See id. at 556.

110. Id. at 558 (emphasis added).

111. See id. at 558-59 (describing main difference between strict liability fail-ure to warn and negligent failure to warn).

112. Ferayorni, 711 So. 2d at 1172 (quoting Anderson, 810 P.2d at 558) (empha-sis in original) (recognizing strict liability failure to warn standard is higher thresh-

old to meet when compared to negligent failure to warn). Yet, the court did notgo as far as making manufacturers the insurers of their products. See id.

113. See Thursby v. Reynolds Metals Co., 466 So. 2d 245, 251 (Fla. Dist. Ct.App. 1984) (explaining when manufacturers have duty to warn).

114. See Ragans v. Miriam Collins-Palm Beach Labs. Co., 681 So. 2d 1173,

1174 (Fla. Dist. Ct. App. 1996) (discussing whose duty it is to decide adequacy ofproduct's warning).

115. See id. (quoting Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 105(Fla. 1989)) (observing general requirements for adequate warnings).

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III. ANALYSIS

A. Application of Design Defect Tests

For Kiley Bechler's design defect claim to prevail, she mustprove Xenadrine fails either the consumer expectation test or therisk-utility test 16 Both tests play a significant role in assessingwhether Xenadrine's design is defective because Florida courts donot specify a preference for either test.117 This Section highlightsthe critical aspects of design defect litigation by applying each testto the facts surrounding Steve Bechler's death." t8

1. Application of the Consumer Expectation Test

A product fails the consumer expectation test when it "fails toperform as safely as an ordinary consumer would expect when usedas intended or in a manner reasonably foreseeable by the manufac-turer."'19 Steve Bechler was an ordinary consumer, takingXenadrine to lose excess weight. 20 Kiley Bechler can argue thatXenadrine failed to perform as safely as an ordinary consumerwould expect because ordinary consumers typically expect to loseweight from taking Xenadrine; they do not expect to develop seri-ous health problems or ultimately die.' 21

Cytodyne, the manufacturer of Xenadrine, might argue thatSteve Bechler was an unintended user because he suffered fromabnormal liver functions and mild hypertension prior to taking

116. For a discussion of tests courts may apply to prove a design defect, seesupra notes 47-86 and accompanying text.

117. See Standard Jury Instructions-Civil Cases (99-1), 778 So. 2d 264, 271(Fla. 2000) (describing how trial courts may apply both tests).

118. For a discussion of the application of the consumer expectation test, seeinfra notes 119-32 and accompanying text. For a discussion of the application ofthe risk-utility test, see infra notes 133-44 and accompanying text.

119. Standard Jury Instructions-Civil Cases, 778 So. 2d at 271 (indicating properjury instruction for consumer expectation test).

120. See Washburn, supra note 3 (recounting Bechler's reason for takingXenadrine).

121. See Complementary and Alternative Medicine: Study calls for major reforms inmarketing of ephedra, HEART DISEASE WKLv., Sept. 7, 2003, at 17 (on file with author)(claiming marketers have made "misleading statements about the safety, use, andefficacy" of ephedra supplements). A study found forty-one percent of websitesmarketing ephedra did not disclose the adverse effects or contraindications relat-ing to supplement use. See id. Fifty-three percent of the websites marketingephedra did not describe the proper dosage. See id. Thirty-four percent of thewebsites marketing ephedra contained misleading statements "which could resultin serious harm to consumers" taking ephedra. Id. "Many of the web-sites in thisstudy contained advertisements claiming no adverse side effects from the dietarysupplement." Id.

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Xenadrine.122 Cytodyne may assert this defense by utilizing the ma-

jority's reasoning in Jennings.123 In Jennings, the court found that

cigarette lighters "are not to be used as children's playthings" and

held that a child was an unintended user of a lighter.1 24 The major-

ity found the child to be an unintended user primarily because the

packaging warned consumers to keep the lighter away from chil-

dren.125 Because the child in Jennings was an unintended user, the

court held that the lighter was not defective in design. 126 Like the

child in Jennings, Bechler may be considered an unintended user

because he suffered from contraindications listed on the Xenadrinelabel.127

Even though Cytodyne has a strong argument that Steve

Bechler was an unintended user, this fact alone does not foreclose

the possibility that Xenadrine is defectively designed. 128 Kiley

Bechler could argue the dissent's position in Jennings.129 She can

claim that her husband was a foreseeable user, or misuser, of

Xenadrine. 130 Steve Bechler used Xenadrine in a manner inconsis-

tent with the label because he exceeded the manufacturer's recom-

122. See Chass, supra note 5, at D5 (describing how Bechler suffered from

ailments that may have contributed to his death); see also Did Xenadrine Kill Balti-

more Orioles' Steve Bechler?, at http://ultimatefatburner.com/xenadfine-steve-bechler.html (last visited Nov. 15, 2004) (explaining Bechler suffered from contra-indicated symptoms). Bechler not only suffered from contraindicated symptoms,he also exceeded the recommended dosage. See id. "[Steve Bechler] was not a

candidate for safe ephedra use. Simply put, Mr. Bechler should never have usedXenadrine." Id. (emphasis in original).

123. SeeJennings v. BIC Corp., 181 F.3d 1250, 1256 (11th Cir. 1999) (findingno design defect because of unintended use). For a discussion of the Jenningsmajority opinion, see supra notes 53-66 and accompanying text.

124. Jennings, 181 F.3d at 1256 (describing children playing with lighters as

unintended users of lighters). "[L]ighters are intended to be used to set fire tothings that are intended to be burned: cigarettes, cigars, candles, etc." Id.

125. See id. (stating warning on package said to "'[k]eep out of reach ofchildren"').

126. See id. (illustrating unintended users may be barred from claiming strictliability design defect).

127. For a discussion of unintended users, see supra notes 72-76 and accompa-nying text.

128. See Standard Jury Instructions-Civil Cases (99-1), 778 So. 2d 264, 271(Fla. 2000) (allowing foreseeable use or misuse in strict products liability claim ofdesign defect). "A product is unreasonably dangerous because of its design if [theproduct fails to perform as safely as an ordinary consumer would expect used asintended or in a manner reasonably foreseeable by the manufacturer] . Id. (emphasisadded).

129. SeeJennings, 181 F.3d at 1261 (Barkett, J., dissenting) (maintaining fore-seeable use is distinct from unintended use).

130. See Standard Jury Instructions-Civil Cases, 778 So. 2d at 271 (leaving optionavailable to argue foreseeable use or misuse when product is not used asintended).

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mended dosage and suffered from hypertension and liverproblems.13 ' Nevertheless, Bechler's use of Xenadrine may havebeen "reasonably foreseeable by the manufacturer," and the prod-uct could still be found unreasonably dangerous, and therefore, de-fective in design. 13 2

2. Application of the Risk-Utility Test

Xenadrine would fail the risk-utility test if "the risk of danger inthe design outweighs the benefits" of the dietary supplement. 133 InFlorida, a reasonable alternative design is not explicitly required toprove a design defect; however, it is a very important factor in per-suading the jury.1 34 Xenadrine-EFX, the ephedra-free version ofXenadrine, could be a reasonable alternative design toXenadrine.135 In fact, the President of Cytodyne Technologiestouted Xenadrine-EFX as a "better-ephedra free product" whencomparing it to Xenadrine, which contains ephedra. 13 6 This evi-dence suggests that an alternative design was available to Cytodyneat the time of Bechler's death. 13 7

131. See Chass, supra note 5, at D5 (describing Steve Bechler's use ofXenadrine as inconsistent with product's label).

132. See generally Standard Jury Instructions-Civil Cases, 778 So. 2d at 272 (notingplaintiff has burden of persuasion).

133. Id. at 271 (describing proper way to apply risk-utility analysis). Theplaintiff will put forth evidence to support the proposition that the risks ofXenadrine outweigh the benefits of Xenadrine. See id. The defendant will putforth evidence that Xenadrine's benefits outweigh any risks or dangers associatedwith the product. See id.

134. See Radiation Tech., Inc. v. Ware Constr. Co., 445 So. 2d 329, 331 (Fla.1983) (illustrating how Supreme Court of Florida finds reasonable alternative de-sign important factor when applying risk-utility test).

The term "unreasonably dangerous" more accurately depicts liability of amanufacturer or supplier in that it balances the likelihood and gravity ofpotential injury against the utility of the product, the availability of other,safer products to meet the same need, the obviousness of the danger, public knowl-edge and expectation of the danger, the adequacy of instructions and warnings onsafe use, and the ability to eliminate or minimize the danger without seriouslyimpairing the product or making it unduly expensive.

Id. (emphasis added).135. See Hearings, supra note 4 (indicating Xenadrine-EFX was available in

early 2002).136. See id. (maintaining Cytodyne's position regarding safety and efficacy of

Xenadrine). In his prepared witness testimony to the House Committee on En-ergy and Commerce, Cytodyne Technologies President Robert Chinery acknowl-edged that he thought Xenadrine-EFX was a "better-ephedra free product." See id.Chinery also noted that Cytodyne Technologies began phasing out advertising andpromotion of Xenadrine in early 2002, and they completely stopped sellingXenadrine in early 2003 - coincidentally, just a short while after Steve Bechler'sdeath. See id.

137. See id. (admitting better alternative to Xenadrine existed at time ofBechler's death).

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When analyzing the utility of Xenadrine under a risk-utility bal-ancing test, the "usefulness and desirability" of the product must beassessed. 138 Obesity in the United States is a growing concern. 139

Every year, more and more Americans are categorized as over-weight or obese.140 Combating obesity is of the utmost importancein maintaining an individual's health, and a safe and effective diet-ary supplement is undoubtedly a useful product.141

If the court performs a risk-utility test it will consider other fac-tors as well. 142 These factors include: the serious nature of SteveBechler's injury, the availability of alternative dietary supplements,Cytodyne's ability to eliminate the ephedra found in Xenadrinewhile maintaining the utility of its product, Bechler's ability to avoidthe dangerous propensities of Xenadrine by properly using theproduct, and Bechler's awareness of the dangers associated with di-etary supplements containing ephedra.1 43 All of these factors willplay a role in determining Cytodyne's liability under the risk-utilitytest. 144

138. SeeWade, supra note 80, at 837 (depicting importance of product's utilityin balancing approach). Professor Wade's first factor in assessing defectiveness is:"The usefulness and desirability of the product - its utility to the user and to thepublic as a whole." Id.

139. See Obesity, Diabetes on the Increase in US, at http://usgovinfo.about.com/library/weekly/aa010803a.htm (last visited Nov. 15, 2004) (listing obesity amongtop health concerns in United States). "Obesity and diabetes are among our toppublic health problems . . . ." Id.

140. See Defining Overweight and Obesity, at http://www.cdc.gov/nccdphp/dnpa/obesity/defining.htm#Adults (last visited Nov. 15, 2004) (stating statistics forobese and overweight Americans). "Results of the National Health and NutritionExamination Survey (NHANES) 1999-2000 indicate that an estimated 64 percentof U.S. adults are either overweight or obese, defined as having a body mass index(BMI) of 25 or more." Id.; see also Obesity Trends, at http://www.cdc.gov/nccdphp/dnpa/obesity/trend/prevschar.htm (last visited Nov. 15, 2004) (finding recentobesity trends across America). "In 2000, 38.8 million American adults met theclassification of obesity, defined as having a body mass index, BMI score of 30 ormore. Between 2000 and 2001 obesity prevalence climbed from 19.8 percent ofAmerican adults to 20.9 percent of American adults." Id.

141. See Hearings, supra note 4 (stating Cytodyne has received responses fromthousands of people who have "lost weight and have improved their quality oflife").

142. See Wade, supra note 80, at 837 (describing factors used when evaluatingdefective and unreasonably dangerous products).

143. See id. (illustrating seven factors used in risk-utility analysis). For a discus-sion of Professor Wade's seven factors, see supra note 80 and accompanying text.

144. See Wade, supra note 80, at 837 (noting factors may be used when assess-ing potential liability).

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B. Application of the Warning Defect Test

Under strict liability failure to warn, a product may be defectivebecause of an inadequate warning.1 45 Manufacturers and sellersmay not avoid liability simply by placing warnings on their prod-ucts. 146 The warning "should contain some wording directed to thesignificant dangers arising from failure to use the product in theprescribed manner, such as the risk of serious injury or death. 1 47

If a warning does not convey the actual risk associated with the useof the product, the warning is inadequate and that product isdefective.

148

Xenadrine's warning label did not communicate that death orserious injury could result from taking the dietary supplement. 149

The label did, however, suggest consulting a physician or licensedhealth care professional if the user suffered from an assortment ofailments. 150 Steve Bechler did not heed this suggestion, as he didnot consult a health care professional before using Xenadrine.1 5

1

An adequate warning must make the danger of a product ap-parent to the consumer. 152 Kiley Bechler could argue thatXenadrine's warning label did not convey a sufficiently forcefulmessage that would adequately warn a reasonable person of the

145. See Ferayorni v. Hyundai Motor Co., 711 So. 2d 1167, 1170 (Fla. Dist. Ct.App. 1998) (observing products may still be rendered defective if warning is inade-quate). "[A] product may be defective by virtue of a design defect, a manufactur-ing defect, or an inadequate warning." Id.

146. See Flynn, supra note 90, at 269 ("[T]he mere existence of a warning isnot dispositive of the adequacy of the warning.").

147. Brown v. Glade & Grove Supply, Inc., 647 So. 2d 1033, 1036 (Fla. Dist.Ct. App. 1994) (describing how inadequate wording may render product defec-tive). "The mere existence of warnings ... is not dispositive of the adequacy of thewarning for several reasons. A warning may be defective not only by virtue of inad-equate warning, but as a result of its location and the manner in which the warningis conveyed." Id. at 1035.

148. See Flynn, supra note 90, at 269-70 (noting both manufacturer and sellermay be liable).

149. See Gary Mihoces, USA TODAY.COM, Ephedrine under baseball's micro-scope, at http://www.usatoday.com/sports/baseball/2003-02-20-cover-ephedrine-baseball x.htm (Feb. 20, 2003) (explaining contents of Xenadrine's warning).

150. See id. (describing warning on Xenadrine bottle). Xenadrine's warninglabel reads: "'Consult a physician or licensed health professional before using thisproduct if you are at risk of, have a family history of, or are being treated for'assorted conditions, including high blood pressure (hypertension) and liverproblems." Id.

151. See Chass, supra note 5, at D5 (noting Bechler had abnormal liver func-tions and mild hypertension prior to taking Xenadrine).

152. See Am. Cyanamid Co. v. Roy, 466 So. 2d 1079, 1082 (Fla. Dist. Ct. App.1984) (stating -product's warning label should clarify any dangerous conse-quences). "To warn adequately, the product must make apparent the potentialharmful consequences." Id.

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product's serious dangers. 153 If the wording of Xenadrine's warn-ing label was not sufficiently frightening, then the warning may bedeemed inadequate and the product defective. 154 Ultimately, theissue of adequacy is reserved for the finder of fact. 155

C. The Relationship Between Warning Defect andDesign Defect

Distinguishing a design defect from a warning defect is criticalwhen assessing a manufacturer's potential liability in a strict prod-ucts liability lawsuit.156 These two areas of strict products liabilitylaw frequently overlap and require manufacturers to strike a bal-ance between a product's design and warning. 157 Therefore, a

153. See id. ("The warning should be of such intensity as to cause a reasonableman to exercise for his own safety caution commensurate with the potentialdanger.").

154. See id. (describing failure to give adequate warning may result in award-ing punitive damages); see also Hildy Bowbeer et al., Warning! Failure to Read thisArticle May Be Hazardous to Your Failure to Warn Defense, 27 WM. MITCHELL L. REv.439, 453 (2000) (noting adequate warnings clearly describe potential dangers toconsumers).

155. See Bowbeer, supra note 154, at 453 ("Ordinarily, the question of whethera given warning is adequate is left to the finder of fact."). One may find JamesSales' seven factors helpful when determining the adequacy of a warning. See id.These factors provide:

First, a warning must be conspicuous. It must be printed in such a man-ner as to assure that a user's attention will be attracted to its message.Second, it should use symbols when appropriate. For example, a skulland crossbones device may be necessary in addition to written warnings ifthe product can cause death. Third, it must sufficiently communicate therisk of danger associated with the product. In that regard, the warningmust be qualitatively sufficient to impart the particular risk of harm.Fourth, the warning must be located where the user is likely to encounterit. In some cases, placement of the warning in an owner's manual orpackage insert will be sufficient; in others, placement on the product it-self may be required. In the latter case, the warning must be placedwhere it will catch the user's eye. Fifth, the warning must be clear andunambiguous. Its content must not be vague or otherwise minimize thelikelihood of the very harm it is seeking to put the user on guard of.Sixth, the warning must be sufficiently broad and encompassing and notunduly limited in scope. If the product can reasonably be put to a num-ber of uses, the warning should address each. Seventh, the warning mustbe undiluted. That is, the manufacturer cannot engage in marketing orpromotional activities, which tend to negate the very dangers the warningspeaks of.

Id. at 453-54 (footnotes omitted).

156. See, e.g., Silverglate, supra note 48, at 14 (explaining relationship betweenproduct warnings and product design).

157. See id. (balancing need for product warnings and product design underFlorida law).

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court's application of the law plays a significant role in assessing amanufacturer's or seller's liability for defective products. 158

In 1976, Florida adopted strict liability as set forth by the Re-statement (Second) of Torts section 402A.159 "Since then, Florida[strict] products liability law has proceeded in anything but astraight line." 160 To provide some clarity, Florida courts haveadopted specific jury instructions for strict product liability claimsof design defect and manufacturing defect.161 The courts, however,have not provided standard jury instructions for strict liability dutyto warn, which has created considerable confusion. 162

Striking the proper balance between the manufacturer's obli-gation to design safe products and holding consumers responsiblefor adhering to product warnings is a problem that has been ad-dressed in other jurisdictions. 163 In Delaney v. Deere & CO.,

1 6 4 theKansas Supreme Court considered that adequate warnings do notalways save a product from being defective in design. 165 While ana-lyzing the effects of placing an adequate warning on a product that

158. See id. at 14-16 (describing results in cases where product designs andproduct warnings are balanced to assess defectiveness).

159. See West v. Caterpillar Tractor Co., 336 So. 2d 80, 87 (Fla. 1976) (follow-ing trend of states adopting § 402A). For a further discussion of West, see supranotes 3940 and accompanying text.

160. Silverglate, supra note 48, at 14. "Even today, considerable confusionand disagreement exist in Florida as to the present state of products liability law."Id.

161. See Standard Jury Instructions-Civil Cases (99-1), 778 So. 2d 264, 272(Fla. 2000) (listing applicable jury instructions for strict products claims); see alsoFlynn, supra note 90, at 272 (positing Florida should provide standard jury instruc-tions on strict liability duty to warn).

162. See Flynn, supra note 90, at 267-68 (indicating need for standard juryinstructions for strict liability failure to warn claims). "Absent this guidance fromthe supreme court, trial lawyers and trial judges scramble to put together jury in-structions of which neither lawyers, nor the judges, can be confident will hold upon appeal." Id. at 268.

163. See Silverglate, supra note 48, at 12 (highlighting case law that describesrelationship of product warnings to design defect).

164. 999 P.2d 930 (Kan. 2000).165. See id. at 946 (holding "an adequate warning does not foreclose a finding

that a product is defectively designed"). The court in Delaney clearly stated theissue as:

Does Kansas follow the portion of Comment j of the Restatement (Sec-ond) of Torts § 402A, which provides that a product bearing an adequatewarning is not in defective condition, or instead, would Kansas now adoptComment I of the Restatement (Third) of Torts § 2, which provides thatan adequate warning does not foreclose a finding that a product is defec-tively designed?

Id. at 940.

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could have been better designed, the court in Delaney described theconflicting positions of the Second and Third Restatements. a66

Commentj of the Restatement (Second) of Torts section 402Aprovides that "a product bearing an adequate warning is not in [a]defective condition."1 67 On the other hand, comment 1 of the Re-statement (Third) of Torts section 2 "provides that an adequatewarning does not foreclose a finding that a product is defectivelydesigned."1 68 In Delaney, the court declined to adopt either Restate-ment's interpretation of the effect of an adequate warning on a de-sign defect and instead chose to adopt its own view. 169 The KansasSupreme Court held that an adequate warning does not foreclosefinding a product defective in design; however, the court did notflatly adopt comment I of the Third Restatement either.170

Florida courts have not explicitly stated their position onwhether an adequate warning precludes a claim for design de-fect.1 71 Their reluctance in adopting a steadfast view has been de-scribed as establishing "a reasonable balance between themanufacturer's obligation to design safe products and its right tohave its warnings and instructions heeded." 172 By not clearly re-jecting or accepting either commentj of Restatement (Second) of

166. See id. at 940 (deciding whether Kansas follows commentj of Restate-ment (Second) of Torts § 402A or comment I of Restatement (Third) of Torts§ 2).

167. Id. (explaining Second Restatement's view on warnings). "Where warn-ing is given, the seller may reasonably assume that it will be read and heeded; anda product bearing such a warning, which is safe for use if it is followed, is not indefective condition, nor is it unreasonably dangerous." RESTATEMENT (SECOND) OFTORTS § 402A cmt. j (1965).

168. Delaney, 999 P.2d at 940 (interpreting Third Restatement's view). TheThird Restatement provides:

Relationship between design and instruction or warning. Reasonable designsand instructions or warnings both play important roles in the productionand distribution of reasonably safe products. In general, when a saferdesign can reasonably be implemented and risks can reasonably be de-signed out of a product, adoption of the safer design is required over awarning that leaves a significant residuum of such risks.

RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2 cmt. 1 (1997) (emphasisin original).

169. See Delaney, 999 P.2d at 946 (choosing not to adopt either Restatements'position).

170. See id. (refusing to adopt Third Restatement's point of view and holdingadequate warnings do not preclude design defect claims).

171. See Silverglate, supra note 48, at 14 (maintaining Florida law "has pro-ceeded in anything but a straight line" since adopting strict products liability doc-trine in West); see also Standard Jury Instructions-Civil Cases (99-1), 778 So. 2d 264,272 (Fla. 2000) (declining to give instruction on strict liability failure to warnclaims).

172. Silverglate, supra note 48, at 14 (claiming Florida law provides appropri-ate balance between manufacturer and consumer rights).

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Torts section 402A or comment 1 of Restatement (Third) of Tortssection 2, Florida is taking a Delaney-like approach to strict productliability claims by combining warning and design defect.173 Thiscase-by-case approach will have a direct impact on the court's assess-ment of Kiley Becheler's claims against Cytodyne Technologies. 174

IV. CONCLUSION

Dietary supplements containing ephedra are a danger for cer-tain people, namely athletes.1 75 Individuals suffering from any oneof fourteen ailments listed on the warning label should not takeXenadrine.1 76 Steve Bechler suffered from two such ailments,which rendered him an unfit candidate to take Xenadrine. 77 Onthe other hand, Xenadrine's warning label did not indicate the seri-ous risks associated with product misuse.178

The tragic events surrounding Steve Bechler's death highlighta murky area of Florida strict products liability law. 179 For example,if the warning label on the bottle of Xenadrine is defective, then

173. See generally Delaney, 999 P.2d at 940-46 (rejecting rigid approach thatproducts with adequate warnings are immune from claims of designdefectiveness).

174. See Silverglate, supra note 48, at 14-16 (analyzing various Florida caseswhere adequate warnings precluded defective design claims).

175. See Metabolife Int'l, Inc. v. Wornick, 264 F.3d 832, 852 (9th Cir. 2001)(claiming over 800 Adverse Event Reports were associated with ephedrine-basedproducts in 1997). "In 1997, for example, the FDA proposed a rule establishing adosage regimen and labeling requirements for dietary supplements containingephedrine alkaloids such as ma haung." Id. The proposed rule was in response toknown serious health risks, such as stroke and death. See id. See generally ProceedWith Caution: How Safe Is Weight Loss Supplement Xenadrine?, ABC NEWS.coM, athttp://abcnews.go.com/sections/GMA/GoodMorningAmerica/GMA01 1121Xenadrinerisks.html (last visited Sept. 24, 2004) [hereinafter Proceed With Cau-tion] (highlighting dangers of Xenadrine). Since 1994, the FDA has received over1,400 complaints of health problems associated with dietary supplements contain-ing ephedra. See id. These consumer complaints included high blood pressure,strokes, and heart attacks. See id.

176. See Proceed With Caution, supra note 175 (listing fourteen ailments thatpreclude Xenadrine use). The fourteen ailments include: "high blood pressure,liver problems, thyroid problems, diabetes, pernicious anemia, nervousness, anxi-ety, depression, seizure disorder, cardiac arrhythmias, stroke, pheochromocytoma,prostate enlargement and psychiatric disease." Id. The Xenadrine label also cau-tions "not to exceed the recommended dosages." Id.

177. See Chass, supra note 5, at D5 (noting Bechler suffered from abnormalliver functions and mild hypertension).

178. See generally id. (noting warning does not explicitly mention that deathcould result from taking Xenadrine). Dietary supplements containing ephedrahave been advertised as natural and safe products. See id.

179. See Silverglate, supra note 48, at 17 (finding Florida law unclear). For adiscussion of the unsettled areas of Florida Strict Liability failure to warn, see supranotes 159-62 and accompanying text.

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Cytodyne Technologies will be held strictly liable.180 If the label isadequate, the warning is not defective, and the court's applicationof the consumer expectation and the risk-utility tests take centerstage.

18 1

Precedent highlights the difficulties of finding a product defec-tive in design after establishing that an adequate warning existed onthe product.182 The current approach of the Florida courts, whilesomewhat complex, is a flexible and reasonable alternative. 183 Thehard-line approach of the Third Restatement, emphasizing productdesign over the use of warnings, seems harsh to manufacturers.1 8 4

On the other hand, the Second Restatement's approach seems toforeclose many legitimate consumer claims.18 5 By sitting on thefence between the two Restatements, Florida appears to be strikinga reasonable balance for both plaintiffs and defendants in warningand design defect cases. 186

After several high profile deaths, the FDA finally intervenedand began taking drastic measures to warn consumers of the dan-gers associated with ephedra.'8 7 First, the FDA suggested that la-bels of dietary supplements containing ephedra should warnconsumers about serious adverse reactions such as heart attacks,seizures, strokes, and death.188 Next, on December 30, 2003, the

180. See generally Bowbeer, supra note 154, at 441 (indicating strict liabilityfailure to warn claims may find otherwise safe products defective).

181. See Brown v. Glade & Grove Supply, Inc., 647 So. 2d 1033, 1036 (Fla. Dist.Ct. App. 1994) (indicating adequate warnings do not foreclose finding productsdefective under design defect).

182. For a discussion of the difficulties the Jennings court had in finding de-fectiveness, see supra notes 53-75 and accompanying text.

183. See Silverglate, supra note 48, at 17 (stating Florida courts should con-tinue using "common sense approach").

184. See RESTATEMENT (THIRD) OF TORTS: PRODucTS LIABILITY § 2 cmt. 1(1997) (emphasizing safer design requirements over mere warnings about danger-ous attributes).

185. See RESTATEMENT (SECOND) OF TORTS § 402A cmt. j (1965) (foreclosingdesign defect claim if adequate warning is present on product).

186. See Silverglate, supra note 48, at 17 (depicting reasonable balance in Flor-ida's approach to balancing product design and product warning).

187. See Christopher Drew, Official Urges Ban Of Ephedra By Baseball, N.Y.TIMES, July 25, 2003, at DI (reporting FDA commissioner urged major league base-ball to ban ephedra). "The FDA has been scrutinizing dozens of deaths, includingsome high school athletes, that might be linked to ephedra." Id. at D3. The FDAreviewed more than 17,000 consumer complaints relating to ephedra-based dietarysupplements. See id.

188. See generally HHS Acts to Reduce Potential Risks of Dietary Supplements Con-taining Ephedra, at http://www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html(Feb. 28, 2003) (announcing series of actions aimed at protecting consumers fromdietary supplements containing ephedra). Based on new medical evidence, theFDA became increasingly concerned about the implications of potentially serious

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FDA announced plans to prohibit the sale of dietary supplementscontaining ephedra.18 9 Finally, on February 11, 2004, the FDA is-sued a ruling that bans all dietary supplements containingephedra.190 In its ruling, the FDA publicly announced that dietarysupplements containing ephedra "present an unreasonable risk ofillness or injury." 191 This ruling became effective on April 12,2004.192

The FDA's ruling sent shockwaves throughout the dietary sup-plement industry, and companies like Cytodyne are heading for thehills. 193 Cytodyne has already changed its name to Nutraquest and

health risks associated with ephedra-based dietary supplements. See id. The FDAtook a proactive approach by proposing a warning label for all ephedra-containingdietary supplements. See id. The FDA noted:

The proposed label [for ephedra containing dietary supplements] warnsabout the risks of serious adverse events, including heart attack, seizure,stroke, and death; cautions that the risk can increase with the dose, withstrenuous exercise, and with other stimulants such as caffeine; specifiescertain groups (such as women who are pregnant or breast feeding) whoshould never use these products; and lists other conditions, such as dis-eases and the use of certain medications, that rule out the use of ephe-drine alkaloids.

Id. As Kiley Bechler's argument goes, had Steve Bechler been informed of thepossibility that he could die from taking Xenadrine, he might still be alive today.See Complaint, supra note 16, at 13 (stating warning label did not warn that use ofXenadrine could lead to death). Kiley Bechler's complaint claims the warning wasinadequate because it failed to warn of the possibility of death. See id. "Nowheredoes it warn on the label that reducing food intake or engaging in exercise whilealso consuming ephedra or Xenadrine RFA-1 can be harmful or even fatal; to thecontrary, the label encourages use of the product in conjunction with dieting andexercise." Id. (emphasis in original).

189. See FDA Announces Plans to Prohibit Sales of Dietary Supplements ContainingEphedra, at http://www.hhs.gov/news/press/2003pres/20031230.html (Dec. 30,2003) (announcing FDA's plans to ban sales of dietary supplements containingephedra). The announcement placed companies on notice of the FDA's intent toissue a final agency ruling. See id.

190. See Dietary Supplements that Present a Significant or Unreasonable Risk:Dietary supplements containing ephedrine alkaloids, 21 C.F.R. § 119.1 (2004).

191. Id. Stating that:Dietary supplements containing ephedrine alkaloids present an unrea-sonable risk of illness or injury under the conditions of use recom-mended or suggested in labeling, or if no conditions of use are suggestedor recommended in labeling, under ordinary conditions of use. There-fore, dietary supplements containing ephedrine alkaloids are adulteredunder section 402(f) (1) (A) of the Federal food, Drug, and Cosmetic Act.

Id.192. See id. (stating date that final rule goes into effect).193. See Michael O'Keeffe, QUEST FOR THE TRUTH: Lawsuits, creditors have

supplement company on the defensive, N.Y. DAILY NEWS, Nov. 3, 2003, at 62 (statingrecent developments in bankruptcy litigation have garnered media attention)."Some fear Nutraquest filed for bankruptcy to duck courtjudgments, protect presi-dent Bob Chinery's personal assets and thwart future lawsuits." Id.

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filed for chapter eleven bankruptcy protection. 194 Nevertheless,both lawyers and creditors are chomping at the bit to get a piece of

the estimated 350 to 600 million dollars in Xenadrine proceeds

alone.1 95 In the meantime, with her case only in the pretrial litiga-

tion phase, Kiley Bechler waits for another painful chapter in her

life to come to a close.

Michael Kane

194. See id. (describing how Cytodyne sold Xenadrine to another companyand then changed its name to Nutraquest).

195. See id. (stating seventy lawsuits are currently pending against Cytodyne,a.k.a. Nutraquest). Most of the pending lawsuits are products liability cases. See id.

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